MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; SURGICAL LIGHTING SYSTEM

Model Number	A-SERIES LIGHTING SYSTEM
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their harmonyair a-series surgical lighting system "flickered off" resulting in a procedure delay.The harmonyair a-series surgical lighting system was rebooted and the procedure was completed successfully.No report of injury.The lighting system was removed from service to await onsite inspection.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the harmonyair a-series surgical lighting system and found the lighting system's commutator slip rings were damaged at the yoke - spring arm connection, likely attributing to the reported issue.The technician replaced the commutator slip rings, tested the lighting system, confirmed it to be operating according to specifications, and returned it to service.The harmonyair a-series surgical lighting system's operator manual states, "troubleshooting 7.6-light flickers on/off during movement.Loss of communication may occur at wall control screen.Contact steris for general troubleshooting and additional information." a 3-year complaint review indicates this to be an isolated event.The device history record (dhr) was reviewed and confirmed that the device was manufactured to specifications.No additional issues have been reported.

• Brand Name: HARMONYAIR
• Common Device Name: SURGICAL LIGHTING SYSTEM
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 20202118
• Report Number: 1043572-2024-00061
• Device Sequence Number: 7546437
• Product Code: FSY
• UDI-Device Identifier: 00724995186548
• UDI-Public: (01)00724995186548
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: A-SERIES LIGHTING SYSTEM
• Device Catalogue Number: LAH01IN01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown